Tissue profile wellness monitor

ABSTRACT

A tissue profile wellness monitor measures a physiological parameter, generates a tissue profile, defines limits and indicates when the tissue profile exceeds the defined limits. The physiological parameter is responsive to multiple wavelengths of optical radiation after attenuation by constituents of pulsatile blood flowing within a tissue site. The tissue profile is responsive to the physiological parameter. The limits are defined for at least a portion of the tissue profile.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/814,229, filed Nov. 15, 2017, entitled “TISSUE PROFILEWELLNESS MONITOR,” which is a continuation of U.S. patent applicationSer. No. 14/599,342, filed Jan. 16, 2015, entitled “TISSUE PROFILEWELLNESS MONITOR,” which is a continuation of U.S. patent applicationSer. No. 13/764,007, filed Feb. 11, 2013, entitled “TISSUE PROFILEWELLNESS MONITOR,” which is a continuation of U.S. patent applicationSer. No. 12/106,969, filed Apr. 21, 2008, entitled “TISSUE PROFILEWELLNESS MONITOR,” which claims priority benefit under 35 U.S.C. §119(e) to U.S. Provisional Application Ser. No. 60/925,811, filed Apr.21, 2007, entitled “TISSUE PROFILE WELLNESS MONITOR.” All of the abovereferenced applications are hereby incorporated by reference in theirentirety herein.

BACKGROUND OF THE INVENTION

Spectroscopy is a common technique for measuring the concentration oforganic and some inorganic constituents of a solution. The theoreticalbasis of this technique is the Beer-Lambert law, which states that theconcentration c_(i) of an absorbent in solution can be determined by theintensity of light transmitted through the solution, knowing the pathlength d_(λ), the intensity of the incident light I_(0,λ), and theextinction coefficient ε_(i,λ) at a particular wavelength λ. Ingeneralized form, the Beer-Lambert law is expressed as:

$\begin{matrix}{I_{\lambda}I_{0,\lambda}e^{{- d_{\lambda}} \cdot \mu_{a,\lambda}}} & (1) \\{\mu_{a,\lambda} = {\sum\limits_{i = 1}^{n}{ɛ_{i,\lambda} \cdot c_{i}}}} & (2)\end{matrix}$

Where μ_(α,λ) is the bulk absorption coefficient and represents theprobability of absorption per unit length. The minimum number ofdiscrete wavelengths that are required to solve EQS. 1-2 are the numberof significant absorbers that are present in the solution.

A practical application of this technique is pulse oximetry, whichutilizes a noninvasive sensor to measure oxygen saturation (Sp0₂) andpulse rate. The sensor has light emitting diodes (LEDs) that transmitoptical radiation of red and infrared wavelengths into a tissue site anda detector that responds to the intensity of the optical radiation afterattenuation by pulsatile arterial blood flowing within the tissue site.Based on this response, a processor determines measurements for Sp0₂ andpulse rate, and outputs representative plethysmographic waveforms. Thus,“pulse oximetry” as used herein encompasses its broad ordinary meaningknown to one of skill in the art, which includes at least thosenoninvasive procedures for measuring parameters of circulating bloodthrough spectroscopy. Moreover, “plethysmograph” as used hereinencompasses its broad ordinary meaning known to one of skill in the art,which includes at least data representative of a change in theabsorption of particular wavelengths of light as a function of thechanges in body tissue resulting from pulsing blood.

Pulse oximeters capable of reading through motion induced noise areavailable from Masimo Corporation (“Masimo”) of Irvine, Calif. Moreover,portable and other oximeters capable of reading through motion inducednoise are disclosed in at least U.S. Pat. Nos. 6,770,028, 6,658,276,6,584,336, 6,263,222, 6,157,850, 5,769,785, and 5,632,272, which areowned by Masimo, and are incorporated by reference herein. Such readingthrough motion oximeters have gained rapid acceptance in a wide varietyof medical applications, including surgical wards, intensive care andneonatal units, general wards, home care, physical training, andvirtually all type of monitoring scenarios.

FIG. 1 illustrates an absorption graph 100 having a dimensionlessvertical axis 101 of relative light absorption and a horizontal axis 102of transmitted wavelength in nm. Shown is a plot of Hb0₂ absorption 110and Hb absorption 120 versus wavelength, both normalized to theabsorption at 800 nm. At red and near IR wavelengths below 970 nm, wherewater has a significant peak, Hb and Hb0₂ are the only significantabsorbers normally present in the blood. Thus, typically only twowavelengths are needed to resolve the concentrations of Hb and Hb0₂,e.g. a red (RD) wavelength at 660 nm and an infrared (IR) wavelength at940 nm. In particular, Sp0₂ is computed based upon a red ratioRed_(AC)/Red_(DC) and an IR ratio IR_(AC)/IR_(DC), which are the ACdetector response magnitude at a particular wavelength normalized by theDC detector response at that wavelength. The normalization by the DCdetector response reduces measurement sensitivity to variations intissue thickness, emitter intensity and detector sensitivity, forexample. The AC detector response is a plethysmograph, as describedabove. Thus, the red and IR ratios can be denoted as NP_(RD) and NP_(IR)respectively, where NP stands for “normalized plethysmograph.” In pulseoximetry, oxygen saturation is calculated from the ratioNP_(RD)/NP_(IR).

SUMMARY OF THE INVENTION

Oxygen saturation is a very useful physiological parameter forindicating the cardiovascular status of a patient, but allows healthcareproviders only a few minutes warning that a patient is potentiallyhaving a medical crisis. A wellness indicator advantageously monitorschanges in a patient's “tissue profile” so as to provide an advancewarning of a deteriorating medical condition. This tissue profile isprovided by a multiple wavelength sensor and a noninvasivemulti-parameter patient monitor, which make blood absorptionmeasurements at more than a red wavelength and an IR wavelength ofconventional pulse oximetry. In one embodiment, described below, bloodabsorption measurements are made at eight wavelengths. Advantageously,this rich wavelength data characterizes a tissue site over a wavelengthspectrum.

FIG. 2 illustrates an example of a tissue profile. In this example, thesensor emits eight wavelengths (610, 620, 630, 655, 700, 720, 800 and905 nm). A tissue profile graph 200 has a NP ratio axis 201 and awavelength axis 202, where the NP ratios are of the formNP_(λ1)/NP_(λ2). This is a generalization to multiple wavelengths of theratio NP_(RD)/NP_(IR) described above for two (red and IR) wavelengths.In order to provide a common scale for these NP ratios, the ratios arecalculated with respect to a reference wavelength, λr, which may be anyof the available wavelengths. Thus, the plotted NP ratios 210 aredenoted NP_(λn)/NP_(λr). Note that the NP ratio at the referencewavelength is NP_(λr)/NP_(λr), =1, which is 700 nm in this example. Inthis example, a tissue profile 210 is plotted for Sp02=97%.

Not surprisingly, the tissue profile 210 has the same general shape asthe absorption curves 110, 120 of FIG. 1. In particular, the ACcomponent of the detector signal relative to the DC component (NP) for aspecific wavelength is proportional to the light absorption at thatwavelength. Thus, the NP ratio magnitudes and hence the points along atissue profile curve are proportional to absorption. Assuming negligibleabnormal Hb species, if SpO₂ is close to 100%, most of the absorption isdue to HbO₂ and, accordingly, the tissue profile is shaped closely tothe HbO₂ absorption curve. As SpO₂ decreases from 100%, the tissueprofile shape is increasing influenced by the shape of the Hb absorptioncurve.

In one embodiment, the tissue profile 210 consists solely of themeasured NP ratios at the sensor wavelengths, i.e. a finite set ofdiscrete values. In another embodiment, the tissue profile 210 consistsof the measured NP ratios and defined NP ratio values between the sensorwavelengths, which are based upon tissue absorption characteristics.That is, the tissue profile 210 is a curve defined over a continuousrange of wavelengths, including the sensor wavelengths. Althoughdescribed above with respect to NP ratios derived from the AC componentof the detector signal, a DC tissue profile may also be defined andapplied to patient monitoring, as described below.

A tissue profile or tissue characterization is described in U.S. patentapplication Ser. No. 11/367,034, filed Mar. 1, 2006 entitledPhysiological Parameter Confidence Measure; a multiple wavelength sensoris disclosed in U.S. patent application Ser. No. 11/367,013, filed Mar.1, 2006 entitled Multiple Wavelength Sensor Emitters; and amulti-parameter patient monitor is disclosed in U.S. patent applicationSer. No. 11/367,033, filed Mar. 1, 2006 entitled NoninvasiveMulti-Parameter Patient Monitor, all of the aforementioned applicationsare assigned to Masimo Laboratories, Inc., Irvine, Calif. and all areincorporated by reference herein.

One aspect of a tissue profile wellness monitor comprises generating atissue profile, predetermining rules and applying the rules to thetissue profile. The tissue profile is responsive to absorption ofemitted wavelengths of optical radiation by pulsatile blood flowingwithin a tissue site. The rules are used to evaluate at least a portionof the tissue profile. A patient condition is indicated according to theapplied rules.

Another aspect of a tissue profile wellness monitor comprises measuringa normalized plethysmograph (NP) to generate a tissue profile, testingthe tissue profile and outputting the test results. The NP is measuredat each of multiple wavelengths of optical radiation, and the NP isresponsive to attenuation of the optical radiation by constituents ofpulsatile blood flowing within a tissue site illuminated by the opticalradiation. The tissue profile is tested against predetermined rules. Thetest results are output as at least one of a display, alarm, diagnosticand control.

A further aspect of a tissue profile wellness monitor comprisesmeasuring a physiological parameter, generating a tissue profile,defining limits and indicating when the tissue profile exceeds thedefined limits. The physiological parameter is responsive to multiplewavelengths of optical radiation after attenuation by constituents ofpulsatile blood flowing within a tissue site. The tissue profile isresponsive to the physiological parameter. The limits are defined for atleast a portion of the tissue profile.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph of oxyhemoglobin and reduced hemoglobin lightabsorption versus wavelength across portions of the red and IR spectrum;

FIG. 2 is a graph of normalized plethysmograph (NP) ratios versuswavelength illustrating a tissue profile for 97% oxygen saturation;

FIG. 3 is a general block diagram of a patient monitoring systemembodiment that implements a tissue profile wellness monitor;

FIG. 4 is a graph of tissue profiles for high saturation, lowsaturation, high carboxyhemoglobin (HbCO) and high methemoglobin(MetHb);

FIG. 5 is a graph illustrating tissue profile changes indicative ofpatient wellness; and

FIG. 6 is a block diagram of a tissue profile wellness monitorembodiment.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 3 illustrates a patient monitoring system 300, which generates NPratios and blood parameter measurements, such SpO₂, HbCO and HbMet,accordingly. The patient monitoring system is advantageously adapted asa tissue profile wellness monitor, as described below. The patientmonitoring system 300 has a patient monitor 302 and a sensor 306. Thesensor 306 attaches to a tissue site 320 and includes a plurality ofemitters 322 capable of irradiating the tissue site 320 with differingwavelengths of light, perhaps including the red and infrared wavelengthsutilized in pulse oximeters. The sensor 306 also includes one or moredetectors 324 capable of detecting the light after attenuation by thetissue site 320. A multiple wavelength sensor is disclosed in U.S.application. No. 11,367,013, filed on Mar. 1, 2006, titled MultipleWavelength Sensor Emitters, cited above. Multiple wavelength sensors,such as Rainbow™-brand adhesive and reusable sensors are available fromMasimo Corporation, Irvine, Calif.

As shown in FIG. 3, the patient monitor 302 communicates with the sensor306 to receive one or more intensity signals indicative of one or morephysiological parameters. Drivers 310 convert digital control signalsinto analog drive signals capable of driving the sensor emitters 322. Afront-end 312 converts composite analog intensity signal(s) from lightsensitive detector(s) 324 into digital data 342 input to the DSP 340.The DSP 340 may comprise a wide variety of data and/or signal processorscapable of executing programs for determining physiological parametersfrom input data. In an embodiment, the DSP 340 executes the processors610, 620, 630 (FIG. 6), described below.

The instrument manager 360 may comprise one or more microcontrollersproviding system management, such as monitoring the activity of the DSP340. The instrument manager 360 also has an input/output (I/O) port 368that provides a user and/or device interface for communicating with themonitor 302. In an embodiment, the I/O port 368 provides thresholdsettings via a user keypad, network, computer or similar device, asdescribed below.

Also shown in FIG. 3 are one or more user I/O devices 380 includingdisplays 382, audible indicators 384 and user inputs 388. The displays382 are capable of displaying indicia representative of calculatedphysiological parameters such as one or more of a pulse rate (PR),plethysmograph (pleth), perfusion index (PI), signal quality and valuesof blood constituents in body tissue, including for example, oxygensaturation (SpO₂), carboxyhemoglobin (HbCO) and methemoglobin (HbMet).The monitor 302 may also be capable of storing or displaying historicalor trending data related to one or more of the measured parameters orcombinations of the measured parameters. The monitor 302 may alsoprovide a trigger for the audible indictors 384, which operate beeps,tones and alarms, for example. Displays 382 include for examplereadouts, colored lights or graphics generated by LEDs, LCDs or CRTs toname a few. Audible indicators 384 include speakers or other audiotransducers. User input devices 388 may include, for example, keypads,touch screens, pointing devices, voice recognition devices, or the like.

FIG. 4 illustrates tissue profile curves 400, which are responsive to Hbconstituents. In this example, the sensor emits eight wavelengths (610,620, 630, 660, 700, 720, 805, 905 nm), which are normalized at 700 nm.Shown is a high saturation profile curve 420, e.g. Sp02˜100% (⋄); a lowsaturation profile curve 440, e.g. Sp02=70% (□); a high HbCO profilecurve 460, e.g. HbCO=30% (Δ); and a high HbMet profile curve 480, e.g.HbMet=6% (X). The profile curves 420-480 each has a head portion 401 atwavelengths less than 700 nm and a corresponding tail portion 402 atwavelengths of greater than 700 nm. As shown in FIG. 4, a tissue profilehead portion 401 has higher values when HbCO (Δ) or HbMet (X) has ahigher percentage value. The head portion 401 has lower values when HbCOor HbMet has a lower percentage value. Also, both the head portion 401and the tail portion 402 have higher values when Sp02 is a highpercentage (⋄) and lower values when Sp02 is a low percentage (□).

FIG. 5 illustrates an example tissue profile 500 utilized as a wellnessindicator. As described with respect to FIG. 4 above, the position orshape of the tissue profile or changes in the position or shape of thetissue profile provide an indication of patient wellness. In particular,position, shape or relative movements of the curve “head” 510 or thecurve “tail” 520 or both indicate potentially detrimental values orchanges in values of hemoglobin constituents. For example, a drop in thetissue profile head 510 or tail 520 below a predefined boundary 530, 540may indicate reduced oxygen saturation. As another example, a rise inthe tissue profile head 510 above a predefined boundary 550 may indicateincreased concentrations of abnormal hemoglobin species, such ascarboxyhemoglobin (HbCO) and methemoglobin (HbMet). Further, relativemovements 570, 580 of the tissue profile 500 faster than a predefinedrate may indicate potentially serious trends in the concentrations ofnormal or abnormal hemoglobin species.

FIG. 6 illustrates a tissue profile wellness monitor 600 having a NPprocessor 610, a tissue profile processor 620 and an output processor630. In an embodiment, these processors 610-630 execute in the DSP 340(FIG. 3) to monitor tissue profile changes. The NP processor 610 hasdigitized sensor signal input 601 from one or more sensor channels, suchas described with respect to FIG. 3, above, and generates normalizedplethysmograph (NP) calculations 612 as described with respect to FIG.1, above.

As shown in FIG. 6, the tissue profile processor 620 is configured tocompare tissue profile changes 612 with respect to predetermined rules603 and communicate the test results 622 to the output processor 630. Asan example, the tissue profile processor 620 may communicate to theoutput processor 630 when a tissue profile portion changes faster than apredetermined rate.

Also shown in FIG. 6, the output processor 630 inputs the tissue profileprocessor results 622 and generates outputs 602 based upon predeterminedoutput definitions 605. For example, if a test profile result is “true”,it might trigger an audible alarm. Rules and corresponding outputs aredescribed in further detail with respect to TABLE 1, below.

In an embodiment, the tissue profile wellness monitor 600 providesoutputs 602 according to TABLE 1, below. The terms listed in TABLE 1 aredescribed with respect to FIG. 6, above. Various other indicators,alarms, controls and diagnostics in response to various combinations ofrules and output definitions can be substituted for, or added to, therule-based outputs illustrated in TABLE 1.

In an embodiment, the tissue profile wellness monitor 600 grades apatient with respect to wellness utilizing green, yellow and redindicators. For example, a green panel light signals that the tissueprofile is indicative of normal blood hemoglobin. A yellow panel lightsignals that changes in the tissue profile shape or position areindicative of potentially problematic changes in blood hemoglobin. A redpanel light signals that the tissue profile is indicative of bloodhemoglobin outside of normal ranges.

TABLE 1 Tissue Profile Rules and Outputs TISSUE PROFILE RULES OUTPUTS Ifall portions of tissue profile are Then illuminate green indicator.within boundaries and relatively un- changing over time If tail dropsfaster than tail trend Then illuminate yellow indicator limit; or headrises faster than head trend limit If tail or head are outside ofboundaries Then illuminate red indicator

A tissue profile wellness monitor has been disclosed in detail inconnection with various embodiments. These embodiments are disclosed byway of examples only and are not to limit the scope of the claims thatfollow. One of ordinary skill in art will appreciate many variations andmodifications.

1. (canceled)
 2. A patient monitor comprising: a front-end interfaceconfigured to receive, from a sensor comprising a light source thatemits light into a tissue site of a patient and a detector that detectsa plurality of wavelengths of the emitted light after attenuation by thetissue site, a signal indicative of the detected light at each of theplurality of wavelengths; and a processor configured to: determine atissue profile curve across each of the plurality of wavelengths basedat least in part on the signal indicative of the detected light at eachof the plurality of wavelengths; analyze a shape of the tissue profilecurve relative to a predefined boundary curve to determine patientwellness; and output an indication in response to determining the shapeof the tissue profile curve exceeds the predefined boundary curve. 3.The patient monitor of claim 2, wherein the indication comprises atleast one of a display, an alarm, a diagnostic, or a control.
 4. Thepatient monitor of claim 2, wherein determining the tissue profile curvecomprises, at least in part: measuring, from the signal, valuesindicative of an amount of light attenuation for at least some of theplurality wavelengths; defining, based on characteristics of the tissuesite, additional values corresponding to at least a portion of awavelength spectrum between the respective wavelengths associated withthe at least some of the plurality of wavelengths; and combining themeasured values at each of the at least some of the pluralitywavelengths with the additional values.
 5. The patient monitor of claim2, wherein the processor is further configured to: output a first signalindicative of patient normalcy when the tissue profile curve is withinthe predefined boundary curve and a rate of change of the tissue profilecurve is less than a maximum rate of change; and output a second signalindicative of alert when at least a portion of the tissue profile curveis outside of the predefined boundary curve and the rate of change ofthe tissue profile curve is greater than the maximum rate of change. 6.The patient monitor of claim 2, wherein the tissue profile curve isindicative of at least one of oxygen saturation of the patient,carboxyhemoglobin of the patient, or methemoglobin of the patient. 7.The patient monitor of claim 2, wherein the tissue profile curvecomprises a first portion and a second portion, and wherein the firstportion is analyzed in comparison to a first portion predefined boundarycurve, and the second portion is analyzed in comparison to a secondportion predefined boundary curve.
 8. The patient monitor of claim 7,wherein the processor is further configured to: provide a firstindication in response to the first and second portions not exceedingthe respective first and second portion predefined boundary curves;provide a second indication in response to one of the first or secondportions exceeding the respective first or second portion predefinedboundary curves; and provide a third indication in response to both ofthe first and second portions exceeding the respective first and secondportion predefined boundary curves.
 9. The patient monitor of claim 2,wherein determining the tissue profile curve comprises, at least inpart: determining, at each of the plurality of wavelengths and based onthe signal, normalized plethysmographs (NPs); and normalize each of thedetermined NPs based on a reference wavelength.
 10. The patient monitorof claim 9, wherein the reference wavelength is one of the plurality ofwavelengths.
 11. A patient monitor comprising: a front-end interfaceconfigured to receive, from a sensor comprising a light source thatemits light into a tissue site of a patient and a detector that detectsa plurality of wavelengths of the emitted light after attenuation by thetissue site, a signal indicative of the detected light at each of theplurality of wavelengths; and a processor configured to: determine atissue profile curve across each of the plurality of wavelengths basedat least in part on the signal indicative of the detected light at eachof the plurality of wavelengths; evaluate a trend in movement of thetissue profile curve relative to a predetermined trend limit todetermine patient wellness; and output an indication in response todetermining the trend in movement of the tissue profile curve exceedsthe predetermined trend limit.
 12. The patient monitor of claim 11,wherein the trend in movement of the tissue profile curve exceeding thepredetermined trend limit indicates advance warning of deterioratingpatient wellness.
 13. The patient monitor of claim 11, whereindetermining the tissue profile curve comprises, at least in part:determining, at each of the plurality of wavelengths and based on thesignal, normalized plethysmographs (NPs); and normalizing each of thedetermined NPs based on a reference wavelength.
 14. The patient monitorof claim 13, wherein the reference wavelength divides the tissue profilecurve into a first portion and a second portion, and wherein the firstportion is evaluated in relation to a first portion predetermined trendlimit, and the second portion is evaluated in relation to a secondportion predetermined trend limit.
 15. The patient monitor of claim 13,wherein the reference wavelength is one of the plurality of wavelengths.16. The patient monitor of claim 13, wherein determining the tissueprofile curve further comprises, at least in part: defining continuousnormalized NP values corresponding to at least a portion of a wavelengthspectrum between the two or more of the plurality of wavelengths basedat least in part on characteristics of the tissue site; and combiningthe normalized NP values at each of the plurality of wavelengths withthe defined continuous normalized NP values.
 17. The patient monitor ofclaim 11, wherein the processor is further configured to: provide afirst indication in response to the first and second portions notexceeding the respective first and second portion predetermined trendlimits; provide a second indication in response to one of the first orsecond portions exceeding the respective first or second portionpredetermined trend limits; and provide a third indication in responseto both of the first and second portions exceeding the respective firstand second portion predetermined trend limits.
 18. The patient monitorof claim 11, wherein the tissue profile curve is indicative of at leastone of oxygen saturation of the patient, carboxyhemoglobin of thepatient, or methemoglobin of the patient.